País: Austràlia
Idioma: anglès
Font: Department of Health (Therapeutic Goods Administration)
Selegiline hydrochloride
Aspen Pharmacare Australia Pty Ltd
Medicine Registered
ELDEPRYL™ _selegiline hydrochloride 5 mg tablets_ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions about ELDEPRYL tablets. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking ELDEPRYL tablets against the benefits the medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT ELDEPRYL IS USED FOR ELDEPRYL tablets are used to treat the symptoms of Parkinson's disease. This is a disease of the brain that affects movement. People with Parkinson's disease do not have enough nerve cells in the part of the brain that controls movement. These nerve cells produce a substance called dopamine. It is a lack of dopamine which causes problems with movement. ELDEPRYL tablets keep dopamine around longer, helping with difficulties in movement. BEFORE YOU TAKE IT _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE ELDEPRYL TABLETS IF: 1. you have ever had an allergic reaction to: • medicines containing selegiline • any of the ingredients listed at the end of this leaflet. 2. you have taken or are taking antidepressants known as selective serotonin reuptake inhibitors (SSRIs) such as Prozac® (fluoxetine), Aropax® (paroxetine) or Zoloft® (sertraline) within the last five weeks. 3. you are taking pethidine (a strong pain killer) or other opiates (check with your doctor or pharmacist). Serious side effects could occur if you start to take ELDEPRYL tablets at the same time as these medicines. 4. you are taking antidepressants known as monoamine oxidase inhibitors (MAOIs) such as Aurorix® (moclobemide), Nardil® (phenelzine) or Parnate® (tranylcypromine) or have taken these medications within the last two weeks. 5. you are taking antidepressants known as tricyclic antidepr Llegiu el document complet
ELDEPRYL Product Information Page 1 of 10 PRODUCT INFORMATION ELDEPRYL (SELEGILINE HYDROCHLORIDE) NAME OF THE MEDICINE ELDEPRYL (selegiline hydrochloride) is a laevorotatory acetylenic derivative of phenethylamine. It is also known as L-deprenyl. Its chemical name is (R)-methyl (-methylphenylethyl) prop-2-ynlamine hydrochloride. The structural formula is: CAS No.: 2079-54-1 DESCRIPTION It is a white to near-white crystalline powder, freely soluble in water, chloroform and methanol and has a molecular weight of 223.75. Each round white tablet contains 5 mg selegiline hydrochloride. Inactive ingredients are: maize starch, cellulose (microcrystalline), mannitol, povidone and magnesium stearate. PHARMCOLOGY _ _ _PHARMACODYNAMICS _ Selegiline is an irreversible inhibitor of monoamine oxidase (MAO), an intracellular enzyme associated with the outer membrane of mitochondria. Selegiline inhibits MAO by acting as a 'suicide' substrate for the enzyme: that is, it is converted by MAO to an active moiety that combines irreversibly with the active site of the enzyme and / or the enzyme's essential flavine adenine dinucleotide (FAD) co-factor. MAOs are currently subclassified into two types, A and B, which differ in their substrate specificity and tissue distribution. In humans, intestinal MAO is predominantly type-A, while most of that in the brain is type-B. At the recommended dose, selegiline has greater affinity with type-B than for type-A active sites and serves as a selective inhibitor of MAO type-B (MAO- B). However, this selectivity is dose-dependent and at higher doses (above Llegiu el document complet